ACTRN12606000361505进行中（未招募）3 期
Multicentre international study to evaluate the effects of capecitabine +/- bevacizumab on disease free survival as adjuvant treatment of colorectal cancer
Australiasia Gastro_Intestinal Trial Group (AGITG)0 个研究点目标入组 2,152 人开始时间: 2006年8月18日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,152
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 ot stated（—）
- 性别
- All
入选标准
- •(1) Histologically proven stage III (stage T2, T3 or T4) and stage II (any one or more of the following – stage T4, lymphatic invasion, vascular invasion, peritoneal involvement, poor differentiation) colorectal cancer (expected ratio 70%:30%). N.B Patients can be Stage II, T3 as long as they have one of the other poor prognostic features. For the purposes of stratification, rectal cancers will be anything below the peritoneal reflection. (2) Patients must have undergone complete resection of the primary tumour without evidence of residual disease. (3) Patients must be randomised to start treatment a minimum of 28 days and maximum of 70 days* after surgery. [If a subject has had a major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start, or there is the anticipated need for major surgical procedure during the course of the study they are not eligible]. (4) World Health Organisation (WHO) Performance Status 0 or 1. (5) Male or female outpatients age greater than or equal to 18 years. (6) Written informed consent given. (7) Life expectancy of greater than or equal to 5 years, in terms of non-cancer-related morbidity.
排除标准
- •(1) Previous chemotherapy, immunotherapy or infra-diaphragmatic radiotherapy.
- •(2) Received any investigational drug or agent/procedure, (i.e. participation in another treatment trial) within 4
- •weeks of randomisation.
- •(3) Moderate or severe renal impairment [creatinine clearance <30ml/min (calculated according to Cockroft-Gault
- •formula–see Appendix 4).
- •(4) Any of the following laboratory values (tests must not have been carried out more than 2 weeks prior to
- •randomisation):
- •a. Absolute neutrophil count (ANC) <1.5 x 109/L
- •b. Platelet count < 100 x 109/L
- •c. Total bilirubin > 1.5 ULN
- •d. ALT, AST > 2.5 x ULN
- •e. Alkaline phosphatase > 2.5 x ULN (ULN = Upper Limit of Normal)
- •(5) Patients requiring chronic use of full dose oral or parenteral anticoagulants, high dose aspirin (>325mg/day),
- •anti-platelet drugs or known bleeding diathesis. Low dose aspirin is allowed.
- •(6) Proteinuria > 500 mg/24 hours.
- •(7) Known coagulopathy.
- •(8) Clinically significant cardiovascular disease
- •[i.e. active; or <12 months since e.g. cerebrovascular accident, myocardial infarction, unstable angina, New
- •York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia
- •requiring medication; or uncontrolled hypertension].
- •(9) Concomitant treatment with sorivudine or its chemically related analogues such as brivudine.
- •(10) Pregnant (positive pregnancy test within 7 days of starting treatment), or lactating women.
- •(11) Sexually active patients of child bearing potential not using adequate contraception (male and female).
- •(12) Previous malignancies other than adequately treated in situ carcinoma of the uterine cervix or basal or
- •squamous cell carcinoma of the skin, unless there has been a disease-free interval of at least 10 years.
- •(13) Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome or inability to take oral
- •medication.
- •(14) Chronic inflammatory bowel disease and/or bowel obstruction and/or active peptic ulcer.
- •(15) History of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the
- •investigator to be clinically significant precluding informed consent or interfering with compliance for oral drug
- •(16) Patients with known allergy to Chinese hamster ovary cell proteins or other recombinant human or
- •humanized antibodies or to any excipients of bevacizumab formulation; or to any other study drugs.
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